An Open-Label Phase 2 Study of MLN0128 (A TORC1/2 Inhibitor) in Combination With Fulvestrant in Women With ER-Positive/HER2-Negative Advanced or Metastatic Breast Cancer That Has Progressed During or After Aromatase Inhibitor Therapy

Objective

To compare the PFS of patients treated with the combination of fulvestrant+daily MLN0128 versus patients treated with single-agent fulvestrant.

Key Eligibility

Female patients aged 18 years or older who are postmenopausalHistologically proven diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence, not amenable to resection or radiation therapy with curative intentHistological confirmation and documentation of ER-positive statusHistological or cytological confirmation and documentation of HER2-negative statusECOG performance status of 0 or 1